Safety pen needle assembly having shielding for patient and non-patient ends
A safety pen needle assembly is provided herein which includes a hub and a needle fixed to the hub. Further, a first shield is provided, along with a second shield which has a biasing element disposed to urge the second shield proximally towards a proximal end of the needle. The assembly further includes a releasable retaining assembly for releasably retaining the second shield in an initial position against the force of the biasing element. A predetermined extent of movement of the first shield causes the retaining assembly to release the second shield. With the second shield being released, the second shield is urged proximally by the biasing element to a second position where the second shield covers the proximal end of the needle. Advantageously, an assembly is provided which allows for passive activation of a shield on a non-patient end of a pen needle assembly by a patient-end shield.
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This application is a continuation of U.S. application Ser. No. 12/922,802, filed on May 3, 2011, now allowed, which is a National Stage Application under 35 U.S.C. §371 of PCT/US2009/037084, filed on Mar. 13, 2009, which claims the benefit of priority to U.S. Provisional Application No. 61/036,138, filed on Mar. 13, 2008, which claims the benefit of priority to U.S. Provisional Application No. 61/036,299, filed on Mar. 13, 2008, which claims the benefit of priority to U.S. Provisional Application No. 61/055,686, filed on May 23, 2008, which claims the benefit of priority to U.S. Provisional Application No. 61/081,878, filed on Jul. 18, 2008, which claims the benefit of priority to U.S. Provisional Application No. 61/084,750, filed on Jul. 30, 2008, the entire contents of these applications being incorporated by reference herein.
BACKGROUND OF THE INVENTIONPen injectors are known in the prior art and typically include a dose-adjustment mechanism for setting a dose, for example of insulin, and a pen needle for insertion into a patient to allow proper drug administration. The pen needle should be single-use and replaced with each administered dose.
The pen needle includes a distal end formed for insertion into a patient and a proximal end for insertion into a drug vial or cartridge located inside the pen injector. The proximal end of the needle will typically have to pierce a septum or stopper provided on the end of the vial or cartridge to access the drug. Devices have been developed in the prior art to shield the distal, or patient, end of the needle after use; particularly, to prevent an inadvertent “needle stick” after use. Even with the distal end being shielded, the proximal, or non-patient end, is exposed.
SUMMARY OF THE INVENTIONA safety pen needle assembly is provided herein which includes a hub and a needle fixed to the hub. Further, a first shield is provided, along with a second shield which has a biasing element disposed to urge the second shield proximally towards a proximal end of the needle. The assembly further includes a releasable retaining assembly for releasably retaining the second shield in an initial position against the force of the biasing element. A predetermined extent of movement of the first shield causes the retaining assembly to release the second shield, and, wherein, with the second shield being released, the second shield is urged proximally by the biasing element to a second position where the second shield covers the proximal end of the needle. Advantageously, with the subject invention, an assembly is provided which allows for passive activation of a shield on a non-patient end of a pen needle assembly by a patient-end shield.
These and other features of the invention will be better understood through a study of the following detailed description and accompanying drawings.
With reference to the figures, a safety pen needle assembly is shown and described herein which provides for shielding on a pen needle assembly, both on the patient (distal) and non-patient (proximal) ends. As used herein, the term “distal”, and derivatives thereof, refer to the direction generally towards the patient end for use, and the term “proximal”, and derivatives thereof, is used to describe the direction away from the patient during use.
With reference to
The hub 12 includes a body 22 having a distal end 24 and a proximal end 26. The proximal end 26 is formed open and shaped to receive a portion of a pen injector body to allow the assembly 10 to be mounted onto a pen injector. Mounting features 28 may be formed on the hub 12 adjacent to the proximal end 26 formed to cooperate with mounting features provided on a pen injector. For example, the mounting features 28 may be threads or a surface configuration, such as a tapered surface for a luer-type mounting, or both.
The needle 14 may be of any needle design, particularly of any pen needle design. The needle 14 includes a distal end 30, formed for insertion into a patient, and a proximal end 32. As shown in the figures, the distal end 30 of the needle 14 extends distally beyond the distal end 24 of the hub 12. The proximal end 32 of the needle 14 may be within the interior of the hub 12 adjacent to the proximal end 26, or may extend proximally from the proximal end 26. The needle 14 may be fixed to the hub 12 using any known technique, such as being adherently fixed to the hub 12.
The first shield 16 is formed to at least partially encircle a portion of the needle 14. The hub 12 includes a transverse wall 34 located between the distal and proximal ends 24, 26 of the hub 12. The first shield 16 is located distally of the transverse wall 34. Preferably, the first shield 16 is moveable from an initial state where the distal end 30 of the needle 14 is exposed to a second state where the first shield 16 covers the distal end 30 of the needle 14.
The second shield 18 is also formed to at least partially encircle a portion of the needle 14. The second shield 18 is located proximally of the transverse wall 34. The second shield 18 is configured to move from a first state where the proximal end 32 of the needle 14 is exposed to a second state where the second shield 18 covers the proximal end 32 of the needle 14. The first biasing element 20 is disposed to urge the second shield proximally towards the proximal end 32 of the needle 14 so as to urge the second shield 18 from its first state to its second state. The first biasing element 20 may be located between a portion of the hub 12 and the second shield 18, such as between the transverse wall 34 and the second shield 18. The first biasing element 20 may be of any known design, including being a compression or coil spring.
With reference to
With reference to
In a preferred arrangement, the hub 12 is formed with a channel 40 into which the second shield 18 is at least partially inserted. The hub locking fingers 36 are formed to deflect into the channel 40 in engaging the second shield 18. In natural, unbiased states, as shown in
The first shield 16 may be urged distally by various ways, including being urged manually. Preferably, a second biasing element 44 (
As shown in
In a preferred arrangement, and with reference to
With reference to
With reference to
With reference to
In the state shown in
As shown in
A locking arrangement may also be provided to limit proximal movement of the first shield 16 once in the final shielding position where the first shield 16 covers the distal end 30 of the needle 14. To this end, and with reference to
As a further variation, the releasable retaining arrangement may be defined by cooperating elements on the first and third shields 16 and 48 which cause relative movement between the first shield 16 and the third shield 48 with the first shield 16 being released. For example, with reference to
By way of non-limiting example, and specifically, with reference to
With proximal movement of the third shield 48 relative to the first shield 16, relative rotation between the first and third shields 16, 48 may be generated due to the tapered surfaces 62, 64 against each other under proximal movement. Preferably, the first shield 16 is non-rotatably held during the proximal movement of the third shield 48. With reference to
As will be appreciated by those skilled in the art, various releasable retaining arrangements are described above. It is to be understood that these arrangements may be used in various combinations and with any of the various embodiments. The releasable retaining arrangement may be defined by one or more movable elements defined on the hub; one or more movable elements defined on one of the shields (e.g., the second shield); and/or an arrangement defined between the shields wherein relative movement (e.g., radial movement) allows for release of the relevant shield.
It is further preferred that the assembly 10 be provided with a locking arrangement to the lock the second shield 18 in the shielding position. With reference to
With reference to
With reference to
In the initial state, the second biasing element 44 applies biasing force to the first shield 16 which, in turn, transmits the biasing force to the third shield 48 via the engagement between the tapered surface 62 and the receiving surface 64. The detents 76 engage the ends of the grooves 74 so as to limit the extent of distal movement of the third shield 48. In this manner, the first shield 16 is retained in the initial state.
During use, the third shield 48 is caused to move proximally. Due to the nesting of the detents 76 and the grooves 74, the third shield 48 is only permitted to move axially, without rotation. Upon a sufficient amount of proximal movement, the detents 76 clear the grooves 74 and enter into clearance areas 80, shown in
With reference to
After completion of the injection, the needle 14 is withdrawn from a patient and the first shield 16 is allowed to be urged further distally by the second biasing element 44 to a shielding position as shown in
It is also preferred that the first shield 16 be locked in the shielding position. With reference to
With removal of the assembly 10 from the injector, the second shield 18 is allowed to move proximally and travel to the shielding state shown in
It is also preferred that that first shield 16, particularly at the reduced diameter portion 88 be provided with a visual indicator area 94 for indicating post-use. The visual indicator area 94 may be a colored and/or textured area which is distinguishable from surrounding portions of the first shield 16. With the first shield 16 being nested in the outer sleeve 46 during use, the visual indicator area 94 is obstructed from view. After use, the visual indicator area 94 becomes visible. The visual indicator area 94 provides a user with a simple manner of identifying whether the assembly 10 has been used. The visual indicator area 94 may be a region or band (e.g., continuous about the reduced diameter portion 88) which is colored and/or textured. Wording (such as “CAUTION-BIOHAZARD”) and/or symbols and/or graphics may also be utilized.
Claims
1. A safety pen needle assembly comprising:
- a hub having at least one resilient hub locking finger;
- a needle fixed to said hub, said needle having a distal end, formed for insertion into a patient, and a proximal end;
- a first shield having a tubular body at least partially encircling a portion of said needle;
- a second shield having a lip and a tubular body at least partially encircling a portion of said needle; and,
- a first biasing means disposed to urge said second shield from an initial state, in which said second shield does not cover said proximal end of said needle, proximally towards said proximal end of said needle,
- wherein, with said second shield in said initial state, said first shield engaging said at least one resilient hub locking finger so as to deflect said at least one resilient hub locking finger radially inwardly into pressing engagement with said lip on said second shield to retain said second shield in said initial state,
- wherein, a predetermined extent of distal movement of said first shield towards said distal end of said needle causes said first shield to come out of engagement with said at least one resilient hub locking finger thus allowing said at least one resilient hub locking finger to release said lip of said second shield, and,
- wherein, with said second shield being released, said second shield is urged proximally by said first biasing means to a second position where said second shield covers said proximal end of said needle.
2. An assembly as in claim 1, further comprising a second biasing means disposed to urge said first shield distally towards said distal end of said needle.
3. An assembly as in claim 1, further comprising a third shield, said third shield having a tubular body at least partially encircling a portion of said needle.
4. An assembly as in claim 3, further comprising a second biasing means disposed to urge said first shield distally towards said distal end of said needle.
5. An assembly as in claim 4, wherein secondary releasable retaining means are provided for releasably retaining said first shield in an initial position against the force of said second biasing means.
6. An assembly as in claim 5, wherein, a secondary predetermined extent of movement of said third shield causes said secondary retaining means to release said first shield.
7. An assembly as in claim 6, wherein, upon release from said secondary retaining means, said first shield traverses said predetermined extent of distal movement under force of said second biasing means thereby causing said second shield to be released.
8. An assembly as in claim 7, wherein, upon release from said secondary retaining means, said first shield is urged distally under force of said second biasing means to a second position where said first shield covers said distal end of said needle.
9. An assembly as in claim 6, wherein, upon release from said secondary retaining means, said first shield is urged distally under force of said second biasing means to a second position where said first shield covers said distal end of said needle.
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Type: Grant
Filed: Dec 19, 2013
Date of Patent: Oct 20, 2015
Patent Publication Number: 20140107586
Assignee: Becton, Dickinson and Company (Franklin Lakes, NJ)
Inventors: Tieming Ruan (Randolph, NJ), Stephen Richards (Holdrege, NE), Eliot Zaiken (Covington, GA), Craig Newman (Montvale, NJ), Vadim Goykhman (Aventura, FL), Joseph Alu (Oakland, NJ), Michael Vincent Quinn (East Hanover, NJ)
Primary Examiner: Bhisma Mehta
Assistant Examiner: Nicholas Meghri
Application Number: 14/134,810
International Classification: A61M 5/32 (20060101); A61M 5/34 (20060101);